FDAFDA · Food and drugs·Recall number Z-1916-2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Published June 5, 2024 · Recall initiated: April 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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